[Update: Drug & Device Law has also released their list of “best” cases, and so I have responded.]

First, a bow to my opponent. I reference the pharmaceutical company defense lawyers from Dechert at Drug & Device Law a lot here on this blog even though, as a plaintiff’s lawyer, I’m always on the other side from them (one might even say they’re on the wrong side of the law) because they write a great blog. They write detailed, passionate arguments about substantive issues of law, and they link liberally, involving others in the conversation. It’s not that I haven’t noticed you folks over at Weil Gotshal with your competing Product Liability Monitor (link nofollowed), but you need to add some hot sauce and link out if you want to roll with the big boys. Maybe it’s because Dechert’s in Philadelphia and Weil Gotshal’s in New York, or maybe it’s because we Philadelphia lawyers punch a little bit harder.

Now, on to the fight. Drug & Device Law has compiled their “Ten Worst Drug/Medical Device Decisions of 2011.” It must have been a Herculean task: from my perspective, you have to look really hard to find court decisions against the pharmaceutical and medical device industry. As I’ve written before, the deck is stacked against innocent people injured by these drugs and medical devices: it’s almost impossible to sue pharmaceutical companies for anything other than inadequate warnings on their labels (a claim that is itself in peril, even as drugs like ActosPradaxa, and Propecia warn of their minor risks but not their major risks), and it’s virtually impossible to sue implant and medical device manufacturers for anything other than violating FDA regulations.

Of course, none of the court opinions on the D&D Law list were really against the drug and medical device companies; no court ever rules that a drug company was negligent or that medical device company has to pay compensation. When a plaintiff “wins” a court decision, that really means the plaintiff gets a chance to prove their case in front of a jury. Instead, when drug and device companies complain about courts, it’s because they think the court should have dismissed the cases entirely, without a trial, without a word of testimony or a shred of evidence shown to a jury. The bulk of the cases cited by Drug & Device Law follow that pattern, with the defense lawyers complaining either that a court didn’t buy some preposterous defense theory or that a court didn’t let a company walk away scot-free after violating FDA regulations and hurting people.

Indeed, the D&D Law list of cases is revealing because of just how reasonable these “worst” court opinions are.  There’s been a lot of press lately about how more Americans are killed annually by prescription medication overdoses than car accidents; coincidentally, D&D Law’s “worst” decision of the entire year, DiCosolo, involved a consumer indisputably killed by a defectively manufactured prescription painkiller patch, and they argue we’re supposed to let the maker of that deadly product walk away from any accountability because the DiCosolo’s weren’t compulsive hoarders that held on to every used disposable product in their house? Because Janssen Pharmaceuticals failed to convince a jury of its ridiculous fentanyl fairy theory? What’s so wrong with letting a jury hear those factual arguments and deciding what’s true and what’s not, the way we’ve settled disputes since ancient times?

Let’s unpack a couple of these “worst” opinions and see just how bad they really are. 
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The lines between conscious sedation, monitored anesthesia care, general anesthesia, and life-threatening central nervous system depression are blurry and thin.  As the death of Michael Jackson and prosecution of his personal physician has brought back into the spotlight (I hope), anesthesia medications like propofol are frighteningly dangerous if used improperly.  It’s not like taking an antihistamine and going to sleep for a couple hours. Even the “long acting” procedural sedation agents like Versed and Fentanyl work for at most an hour, whereas the short-acting agents like Propofol last for only a couple minutes.  They have to be constantly administered and the patient has to be constantly monitored.

We review a lot of medical malpractice cases, so it feels like I see the same tragic story once a month, either in the press or in cases at our firm. Recently, “parents of student who died after dental surgery sue for malpractice“:

The parents of a Woodstock teen who died 10 days after losing oxygen during a routine wisdom tooth surgery March 28 in Columbia are suing the anesthesiologist and the oral surgeon involved for medical malpractice, according to court records filed Nov. 30.

The suit claims that Dr. Krista Michelle Isaacs, the anesthesiologist, and Dr. Domenick Coletti, the oral surgeon, were negligent in their care of Olenick and failed to resuscitate her after her heart rate slowed to a “panic level” of 40 beats per minute and her body began losing oxygen.

Yahoo has an article examining the merits of wisdom tooth removal, but it seems the type of surgery wasn’t really the problem, nor the use of improper surgical techniques.  It happened to involve dental surgery, but it could have been any type of surgery; Ms. Olenick’s death was perhaps another example of anesthesia malpractice:

According to Dr. David Fowler, the state’s chief medical examiner, Olenick was first given a standard dose of anesthesia during the procedure that did not “get her deep enough so she was fully anesthetized.” More anesthesia was then administered by Isaacs, which was also standard procedure, Fowler said in an interview.

At approximately 8:05 a.m., Olenick began to experience bradycardia, or a slowing of her heart rate, according to the lawsuit. “A little while later, the oxygen saturation in her blood started dropping,” Fowler said. Shortly thereafter, according to the autopsy report, Olenick went into hypoxic arrest.

The part of Ms. Olenick’s story that raised my eyebrows is how the patient showed bradycardia and then a little later showed a drop in oxygen saturation followed by hypoxia and cardiac arrest.  Bradycardia is a known side-effect of many anesthesia agents (consider this 1997 study on propofol), including Versed, which was likely used in the oral surgery procedure.  (On a comment on a blog called “No Midazolam,” it appears Ms. Olenick’s mother confirmed that Versed was one of the drugs used.)

Once a patient under anesthesia shows bradycardia, that’s a medical emergency, and action needs to be taken immediately. Here’s a medical malpractice case from Texas describing a similar situation:

[D]uring surgery, Mark had progressive bradycardia, an abnormally slow beating of the heart, which is a condition that is consistent with inadequate ventilation. This condition can lead to cardiac arrest. According to Dr. Fromm, if Mark was in good health before the operation and if he had been well-ventilated during surgery, he would have survived a sudden cardiac arrest during the surgery.

Adequate ventilation is critical during any surgery under general surgery, and I suspect that it contributed to Ms. Olenick’s brain damage, but another issue jumps out at me.


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As a Yale alum, I was shocked and horrified by the death of Annie Le, a Yale School of Medicine student murdered just a week before her own wedding. Like the Petit family murders, the crime was just a depraved act by a stranger, despite attempts by some to downplay it as a “crime of passion” or “workplace violence,” as if any rape-murder were less evil if the perpetrator had delusions of attachment at the time of the crime or if they happened to be employed by the same company. She was targeted and it was murder; we know that from the guilty plea. It may have been sexual assault, too; Raymond Clark submitted an Alford plea to that.

Last week, just before the statute of limitations for negligence would run, Le’s estate filed a wrongful death lawsuit against Yale:

The estate of former pharmacology student Annie Le GRD ’13 filed a wrongful death lawsuit against the University in New Haven Superior Court on Tuesday, alleging that pervasive sexual harrassment at the University “emboldened” her killer, Raymond Clark III, who is serving a 44-year sentence for the murder and who the suit claims was hired through Yale’s negligence.

The complaint is here. While I can understand why the estate’s lawyers, Joseph Tacopina (Greenfield, who knows him, has a bit more about him here) and Paul Slager, want to tie Le’s death to the Title IX problems at Yale and thereby generally show university indifference to women’s safety, I don’t see that serving as enough of a factual basis for an independent legal claim. There’s no clear causal connection between Yale’s sexual harassment / sexual assault policies and Le’s death; as far as I’ve seen, Le never filed any sort of sexual harassment or sexual assault claim at the school, so it’s hard to claim that, if those policies had been better, she wouldn’t have been murdered.

Although there’s technically an inadequate security claim in there arising from the security of the building and the failure to search for Le, I don’t see the causal connection there: from all accounts, it seems that, if they had searched earlier, they just would have found Le’s body earlier, rather than preventing the attack.

The strongest claim is predicated on the hiring of Clark himself, and that claim has a bit more behind it and a much closer connection to her death:

The complaint alleges that Yale was negligent in its screening of Clark, who had shown “a violent propensity towards women” before he was hired in 2004. As police began to investigate his possible involvement in Le’s death in mid-September 2009, the New Haven Independent reported that Clark forced his high school girlfriend to have sex with him when they were students …

In addition to Clark’s records, the suit alleges Yale had access to information about Clark’s violent past because the University also employed Clark’s sister and brother-in-law as laboratory technicians in the 10 Amistad St. building where Le was killed. Those two employees were both “well aware” of Clark’s past behavior given their relationship to him, the suit claims.

This sort of negligent hiring claim isn’t novel. The primary case in that field is Ponticas v. KMS Investments, 331 N.W.2d 907 (Minn. 1983). It wasn’t the first, but it’s probably the most frequently cited, and it set the path for tort liability where an employer is alleged to have negligently hired a dangerous or incompetent person:

Liability is predicated on the negligence of an employer in placing a person with known propensities, or propensities which should have been discovered by reasonable investigation, in an employment position in which, because of the circumstances of the employment, it should have been foreseeable that the hired individual posed a threat of injury to others.

Connecticut’s appellate court has already adopted the same theory in Seguro v. Cummiskey, 82 Conn.App. 186 (2004):

A review of case law in other jurisdictions reveals that employers may be directly liable for the negligent hiring, retention or supervision of an employee who, through a tortious act, injures a third party. See, e.g., Island City Flying Service v. General Electric Credit Corp., 585 So. 2d 274, 276 (Fla. 1991)(“employer is liable for the willful tort of his employee committed against a third person if he knew or should have known that the employee was a threat to others”); Henley v. Prince George’s County, 305 Md. 320, 336, 503 A.2d 1333 (1986) (employer has duty to use reasonable care to select employees competent and fit for work assigned to them); Ponticas v.K.M.S. Investments, 331 N.W.2d 907, 910 (Minn. 1983) (“person injured by a negligently retained employee may recover damages from the employer”); Di Cosala v. Kay, 91 N.J. 159, 170-71, 450 A.2d 508 (1982) (“employer whose employees are brought into contact with members of the public in the course of their employment is responsible for exercising a duty of reasonable care in the selection or retention of its employees”); Soares v. Ann & Hope of Rhode Island, Inc., 637 A.2d 339, 346 (R.I. 1994) (recognizing “`direct liability of an employer to third parties who are injured by acts of unfit, incompetent, or unsuitable employees’”); Welsh Mfg. v. Pinkerton’s, Inc., 474 A.2d 436, 440 (R.I. 1984) (“employer may be directly liable for wrongful acts of its negligently hired employee”); J. v. Victory Tabernacle Baptist Church, 236 Va. 206, 208-209, 372 S.E.2d 391 (1988) (recognizing tort of negligent hiring).

Unfortunately, it looks like a hard sell for the Le estate.
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Big news across the internet yesterday after “Jackass” star Ryan Dunn and a passenger died in an early-morning one-car crash out near West Goshen, Pennsylvania:

Dunn, 34, of West Chester, was reportedly driving his 2007 Porsche at 2:38 a.m. on the Route 322 bypass westbound in the area of Route 100 when he went off the road, according to statement issued Monday morning by West Goshen Township police.

Police said that upon arrival they found the car off the road in the woods engulfed in flames. Scorch marks were still visible at the scene just before noon on Monday, as well as a mangled guardrail and splintered trees where the car apparently left the road.

About two hours before the crash a photo was posted on Dunn’s twitter page, depicting Dunn and two other men apparently drinking.

Jalopnik has a little more about the car and the circumstances. The passenger has been identified as Zac Hartwell. Roger Ebert may have summed up the thoughts of many, but let’s not forget that Dunn and his friends weren’t just drinking, they were paying customers at a bar. Pennsylvania’s Dram Shop Act, 47 P.S. § 4-493, makes it unlawful:

[f]or any licensee or the board, or any employe, servant or agent of such licensee or of the board, or any other person, to sell, furnish or give any liquor or malt or brewed beverages, or to permit any liquor or malt or brewed beverages to be sold, furnished or given, to any person visibly intoxicated, or to any minor…

As is well-settled law, proving a drunk driving lawsuit in Pennsylvania is a two-step process: “A violation of this statute is deemed negligence per se, and the defendant will be held liable if the violation is the proximate cause of the injuries. Thus, in order for [injured plaintiffs] to recover, they must prove two things: (1) that an employee or agent of Appellee served the decedent alcoholic beverages at a time when he was visibly intoxicated; and (2) that this violation of the statute proximately caused his injuries and ultimate death.” Fandozzi v. Kelly Hotel, Inc., 711 A. 2d 524 (Pa. Sup. Ct. 1998).

The photo on Twitter of Dunn and his friends doesn’t necessarily mean Dunn and his friends were “visibly intoxicated,” but it certainly doesn’t rule it out, either. An employee of the bar he was at, Barnaby’s, claims “he didn’t seem intoxicated,” but that’s no surprise — the alternative would be to admit illegally serving alcohol to a visibly intoxicated individual and thus admit liability.

[UPDATE: Since this post was written, Dunn’s toxicology report has been released, showing a blood-alcohol level of 0.196, more than double the legal limit of 0.08. Although there’s no BAC at which a person is, as a matter of law, visibly intoxicated, it seems more than a little suspect that Dunn “left hop, skip, jumping” and then had a BAC of 0.196 a half-hour later. He would likely, at a minimum, slur his speech and have lose his balance at 0.196, and would more likely be stumbling and near the point of blackout. The BAC level might be admissible at trial as evidence (Pennsylvania law isn’t clear on that), but even if not, there’s other evidence of intoxication to prove liability against the bar. Finally, although it appears the bar won’t face criminal charges, the absence of a criminal conviction doesn’t have any effect on a later civil lawsuit.]

The accident was just after 2am, when the liquor licensees close. Let’s assume for the moment that Dunn was “visibly intoxicated” and thus improperly served more alcohol or that, at a minimum, he was too impaired to drive. What would that mean for his Hartwell who, the bar’s insurance company will say, “willingly” got in a vehicle with a drunk individual known for his risk-taking behavior?


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Over at the WSJ Law Blog:

A factual situation: A woman gets pregnant. Six weeks later, the father is killed in an accident.

The legal question: May the child of the father, who was still very much in utero when the father was killed, later bring a wrongful-death action against his father’s killer?

The

One of the big issues that’s been floating around the personal injury / wrongful death world over the past few years is the extent to which states can recoup the money they spent on an injured person’s care if that person later sues the person who caused the injury and obtains a settlement.

The Supreme

At the Fulton County Daily Report:

For $95, plaintiffs lawyers can buy a book that teaches them how to appeal to jurors’ basic survival instincts, those that emanate from humans’ “Reptilian” brains. …

But in a DeKalb County wrongful death trial last month, [Plaintiffs lawyer Don] Keenan found that defense lawyers will also buy the book, “Reptile: The 2009 Manual of the Plaintiff’s Revolution” — and use it against him.

Representing a movie theater and a security company accused of not doing enough to prevent a fatal gang shooting in the theater parking lot, W. Winston Briggs and Matthew G. Moffett read from the book and referred to it during closing arguments.

One of their PowerPoint slides read, “Let’s see if we can scare them/It could have been anyone killed out there … because it’s a public danger there … but if you give us $ that will somehow eliminate this danger/They call this their ‘reptile’ strategy.”

The jury rendered a defense verdict.

Here’s what I don’t understand: how is a book written by the plaintiff’s lawyer relevant to the facts of the case?

The Georgia Rules of Evidence provide:

Evidence must relate to the questions being tried by the jury and bear upon them either directly or indirectly. Irrelevant matter should be excluded.

The jury wasn’t asked their thoughts and feelings about Mr. Keenan’s advocacy methods. They weren’t compelled, by force of the state, to leave their work and their families to render a verdict on the Reptile book. They were there because, as the article says, “21-year-old Jesus Silencio was shot to death in the parking lot of the Regal Hollywood 24 movie theater on Interstate 85” and his father, on Mr. Silencio’s behalf, brought suit against the theater and its security company.

Reptile has nothing to do with those facts. If the book suggests lawyers do anything inappropriate, that, too, is irrelevant: if a lawyer uses improper advocacy methods at trial, the judge will give corrective instructions to the jury or, if need be, declare a mistrial.

The case was about, and should have remained about, Mr. Sliencio’s claims against the theater. Somehow, it became a referendum on Mr. Keenan, and an unfair one at that. Was Mr. Keenan allowed to show the jury how many times the defense lawyers have been threatened with sanctions for spoliating evidence? Could he have copies of all the seminars at the Defense Research Institute that the defense lawyers attended? Was he allowed to introduce evidence establishing how insurance companies — including the Defendants’ insurer, the real party at interest — spend millions every year on propaganda to taint juror’s perceptions of the civil justice system?

Or were the defense lawyers allowed to cast stones from their glass houses?


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JURIST Paper Chase reports:

US security firm Blackwater [JURIST news archive] on Wednesday reached a settlement agreement in seven federal lawsuits filed by Iraqi citizens. The suits claimed that Blackwater, now known as Xe, created a reckless culture [AP report] that resulted in numerous deaths, including the deaths of 17 Iraqi civilians [JURIST reports]